Replimune will resubmit its biologics license application for RP1, a melanoma therapy, after two prior FDA rejections. The company said it expects to refile its application in the coming days, characterizing the pathway forward as “collaborative dialogue” with the regulator. The resubmission timing comes amid changes in FDA leadership. Analysts cited the departures of Vinay Prasad and later Commissioner Marty Makary as part of the shifting context, and Replimune said the FDA plans to treat the submission as an “urgent matter.” Operationally, the focus now shifts to what the FDA views as resolved—whether protocol clarity, efficacy/safety arguments, or the evidentiary package. For oncology developers, the case highlights how regulatory continuity and internal leadership dynamics can materially affect review trajectories.